Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Phase 3

Completed

• Conditions: Acute Gouty Arthritis
• Interventions: Drug: Canakinumab 150mg in prefilled syringe

• Registration Number: NCT01431638
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-25
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2013-05-09
• Study Completion: 2013-05-09
• Results First Submitted: 2021-04-06
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-28
• Last Update Submitted: 2021-06-28
• Results First Posted: 2021-07-19
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canakinumab 150mg	Canakinumab 150mg in prefilled syringe	Canakinumab 150mg in prefilled syringe subcutaneously

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Adverse Events	From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Secondary Outcome Measures

Name	Time	Method
Probability of New Gout Flares at End of Study	Up to Day 337	The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.
Number of Participant With New Flares	up to 36 weeks	The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.
Change From Baseline in Pain Intensity on a 5-point Likert Scale	Baseline, upto 14 days post-dose	A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time	Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose	Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint	Baseline, 7 days post-dose	Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment	48 weeks post-dose	Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).
Number of Participants Responded for Physician's Global Assessment of Response to Treatment	7 days post-dose	The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇱🇹 Vilnius, Lithuania